NCT05223517招募中不适用
Effect of Acupuncture for Chronic Pelvic Pain in Women: a Randomized Clinical Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2022年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
研究概览
简要总结
The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 and
- •Chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 6 months duration.
- •Having not used medications, other than rescue medicine, or therapies for chronic pelvic pain for at least 4 weeks before randomization, and consenting not to use throughout the process of the research.
- •Completing Weekly Pain Diary for at least three week during the four-week run-in period, and at least two of the worst pain scoring ≥4 on the Numeric Rating Scale.
- •Volunteering to participate the trial and signing written informed consent.
排除标准
- •Cyclical chronic pelvic pain, such as only with dysmenorrhea.
- •Endometriosis.
- •Adenomyosis.
- •Complex ovarian cyst.
- •Accessory cyst >5cm.
- •Uterine fibroids >5cm.
- •Malignant disease.
- •Anterior sacral neurectomy or uterine sacral nerve ablation before or scheduled in the next 6 month.
- •Irritable bowel syndrome.
- •Symptomatic urinary tract infection.
- •Acute pelvic inflammation.
- •Uncontrolled vaginitis.
- •Lactation period, pregnancy, or fetation planned in the next 6 months.
- •Sever disorders in heart, lung, brain, liver, kidney and hematopoietic system, or obvious psychiatric or cognitive dysfunction.
- •Poor adherence.
结局指标
主要结局
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
时间窗: Weeks 5-8
Participants will rate their average chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of the four weeks.
次要结局
- Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.(Weeks 1-4, 9-12, 13-16, 17-20.)
- Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on the worst pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
- The change from baseline in the numerical rating scale (NRS) score on average pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
- The change from baseline in the numerical rating scale (NRS) score on the worst pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
- Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
- Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
- The change from baseline in the interferes score of Brief Pain Inventory (BPI) short form.(Weeks 4, 8, 12, 16, 20)
- The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) .(Weeks 8 and 20)
- The change from baseline in the Female Sexual Function Index (FSFI) score.(Weeks 8 and 20)
- The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).(Weeks 4, 8 and 20)
- The change from baseline in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.(Weeks 4, 8 and 20)
研究者
Yuanjie Sun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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